In the European Unoin, a new Medical Device Regulation (MDR) became effective from May 26, 2021. The new MDR includes a mandate for Unique Device Identification (UDI). The UDI is intended to facilitate the traceability of all medical devices sold in the EU. It also helps to increase the effectiveness of post-market safety-related activities. Devices must be marked with a device identifier (DI) and each batch of the product should be marked with a production identifier (PI).

The UDI helpdesk was worked out as an instrument for economic operators. It helps to find what obligations and requirements introduced by the new UDI system, including UDI assignment, labelling, and registration of devices. It also will help get an understanding of the European Medical Devices Nomenclature (EMDN), which is required by the MDR.

Thus, the obligation for UDI assignment is applicable from May 26, 2021 for medical devices and the obligation for submission of UDI data in the EUDAMED database will become applicable from November 26, 2022 for medical devices.

There are six modules that were created in support of MDR’s provisions. These modules relate to:

• actor registration
• unique device identification (UDI) and device registration
• notified bodies and certificates
• clinical investigations
• performance studies
• vigilance and market surveillance
  

These modules are combined in the EUDAMED database that allows notified bodies, medical device companies, consumers, regulators, and other stakeholders to access the latest data on medical devices for sale in Europe.

Information related to the EUDAMED is also provided on the UDI helpdesk page.

To access the UDI helpdesk, please follow the link.

‍

The information has been prepared by the GMA Consult Group team. ‍

GMA Consult Group provides a full cycle of international type approval and global market access services for IT, Telecom, and industrial electrical products in all countries throughout the world. With proven expertise in worldwide regulations, compliance, certification, and conformity assessment, GMA Consult Group can help your company speed up the access to any market with almost zero efforts from your side.

Need your own guide to the world of certification and approvals? Don't hesitate to contact us via info@gma.trade.